The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

8776–8800 of 21595

  • ModerateFDA (Food)·F-1769-2019·2019-07-31

    C&S Wholesale Grocers Recalls Archer Farms Coleslaw Due to Temperature Issues

    C&S Wholesale Grocers is recalling Archer Farms Homestyle Coleslaw Salad sold at two New York Target stores because it was not held at the appropriate temperature during transportation.

    Product
    HOMESTYLE COLESLAW SALAD 1LB - ARCHER FARMS; UPC: 8523901860
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1746-2019·2019-07-31

    Fairlife Chocolate Milk Recalled for Temperature Control Failure During Transport

    C & S Wholesale Grocers is recalling Fairlife Lactose Free 2% Chocolate Milk sold at two New York Target stores because it was not held at appropriate temperatures during transportation.

    Product
    FAIRLIFE LACTOSE FREE 2% CHOCOLATE MILK - 52 FL OZ, UPC:5631200279
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1503-2019·2019-07-31

    Pharma-Natural Recalls Dayma Pain Gel for Manufacturing Violations

    Pharma-Natural Inc. is recalling 1,000 jars of Dayma SUPER FORTE XL10 Pain Relieving Topical Analgesic Gel due to current good manufacturing practice violations.

    Product
    Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical Analgesic Gel, 4 Oz (113.4 g) jar, Distributed by: Biosfera International Distribution, LLC., Miami Lakes, FL 33016, NDC 63788-118-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2021-2019·2019-07-31

    Siemens AXIOM Artis dTC X-ray Generator Recall for Power Supply Defect

    Siemens is recalling 98 AXIOM Artis dTC units because a power supply tolerance issue may cause generator failure, preventing X-ray imaging.

    Product
    AXIOM Artis dTC, Model Number 7413078
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2082-2019·2019-07-31

    Medical Intelligence Recalls iGuide System Software Due to False Verification Alerts

    Medical Intelligence Medizintechnik GmbH is recalling iGuide System software versions 2.2.0, 2.2.1, and 2.2.2 because the Constant Correlation Check may incorrectly demand verification scans.

    Product
    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1679-2019·2019-07-31

    Chobani Plain Nonfat Greek Yogurt Recalled for Temperature Control Failure

    C & S Wholesale Grocers is recalling Chobani Plain Nonfat Greek Yogurt sold at two New York Target stores because the product was not held at the appropriate temperature during transportation.

    Product
    CHOBANI PLAIN NONFAT GREEK YOGURT - 32OZ, UPC: 9470001013
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1609-2019·2019-07-31

    Taylor Farms Organic Lettuce Recalled for Temperature Control Failure

    C & S Wholesale Grocers is recalling Taylor Farms Organic Baby Spring Mix and Baby Spinach Lettuce sold at two Target stores in New York due to a mechanical malfunction that prevented proper temperature control during transportation.

    Product
    TAYLOR FARMS ORGANIC BABY SPRING MIX & BABY SPINACH LETTUCES - 5.5OZ PACKAGE, UPC: 0223047612
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1784-2019·2019-07-31

    International Delight French Vanilla Creamer Recalled for Temperature Control Failure

    C & S Wholesale Grocers is recalling International Delight French Vanilla Creamer sold at two Target stores in New York because the product was not held at an appropriate temperature during transportation.

    Product
    INTERNATIONAL DELIGHT FRENCH VANILLA CREAMER - 1.5QT UPC: 4127102241
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1703-2019·2019-07-31

    Daisy Sour Cream Recalled for Temperature Control Failure During Transport

    C & S Wholesale Grocers is recalling Daisy Original Sour Cream sold at two New York Target stores because it was not held at the appropriate temperature during transportation.

    Product
    DAISY ORIGINAL SOUR CREAM - 24OZ, UPC: 7342000024
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1891-2019·2019-07-31

    Starbucks Caffe Mocha Iced Espresso Recalled for Temperature Control Failure

    C & S Wholesale Grocers is recalling Starbucks Caffe Mocha Iced Espresso Classics sold at two New York Target stores due to a mechanical malfunction that prevented proper temperature control during transportation.

    Product
    STARBUCKS CAFFE MOCHA ICED ESPRESSO CLASSICS - 40 FL OZ UPC: 4850020132
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1506-2019·2019-07-31

    Pharma-Natural Recalls NEOGEN-D Cough Syrup Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling 2,052 bottles of NEOGEN-D cough syrup because the product was manufactured with current good manufacturing practice violations, including a lack of process and cleaning validation.

    Product
    NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-699-16.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1982-2019·2019-07-24

    Beckman Coulter Recalls Kaluza C Flow Cytometry Software Due to Compatibility Issues

    Beckman Coulter is recalling Kaluza C Flow Cytometry Software because compatibility issues with Microsoft Windows updates render the software unusable, potentially delaying the reporting of results.

    Product
    Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual Educati
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1963-2019·2019-07-24

    Zimmer Biomet Recalls Ultra-Drive Irrigation Tubing Assembly Due to Shelf Life Data

    Zimmer Biomet is recalling 8,478 Ultra-Drive Irrigation Tubing Assemblies because the company lacks sufficient data to support the labeled 10-year shelf life.

    Product
    Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1980-2019·2019-07-24

    Elekta Unity Radiation Therapy System Software Recall

    Elekta is recalling 12 Unity systems because a software defect prevents users from inspecting stored alignment values during quality assurance.

    Product
    Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical pract
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1969-2019·2019-07-24

    Pharmaceutical Innovations Recalls ElectroMist Electrode Conductivity Spray Solution

    Pharmaceutical Innovations, Inc. is recalling ElectroMist electrode conductivity spray solution due to potential failure in antimicrobial effectiveness testing.

    Product
    ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1979-2019·2019-07-24

    Roche Tina-quant lgA Gen.2 Assay Recalled Due to Reagent Contamination

    Roche Diagnostics is recalling Tina-quant lgA Gen.2 assays due to reagent contamination causing calibration and quality control failures.

    Product
    The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1970-2019·2019-07-24

    Pharmaceutical Innovations Recalls ElectroMist Conductivity Spray Solution

    Pharmaceutical Innovations, Inc. is recalling ElectroMist Electrode Conductivity Spray Solution due to potential failure in antimicrobial effectiveness testing.

    Product
    ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1966-2019·2019-07-24

    Datascope Intra-Aortic Balloon Catheter Recalled for Reversed Date Labels

    Datascope is recalling 471 Sensation Plus Intra-Aortic Balloon Catheters because the outer cartons displayed the manufacture and expiry dates in reverse.

    Product
    Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stab
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1984-2019·2019-07-24

    Medline Recalls Anti-Fog Solution in Surgical Kits Due to Degradation

    Medline Industries is recalling 14,550 units of anti-fog solution in surgical kits because the chemical properties may have degraded, preventing proper defogging.

    Product
    Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN LA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1941-2019·2019-07-24

    Datascope CS100 Intra-Aortic Balloon Pump Recalled for Battery Maintenance Issues

    Datascope Corp. is recalling CS100 Intra-Aortic Balloon Pumps because improper battery maintenance may result in less than minimum run time. Revised labeling and training are being offered.

    Product
    CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1962-2019·2019-07-24

    Zimmer Biomet Recalls Ultra-Drive Hose/Drape Assembly Due to Shelf Life Data

    Zimmer Biomet is recalling 8,478 Ultra-Drive Hose/Drape Assemblies because there is insufficient data to support the labeled 10-year shelf life.

    Product
    Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1581-2019·2019-07-24

    Valley Processing Recalls Single Strength Apple Juice Due to Patulin

    Valley Processing, Inc. is recalling 11,504 gallons of single strength apple juice because patulin levels exceeded 50 ppb. The product was distributed in California.

    Product
    Single Strength Apple Juice shipped in 5700 gallon tanker. The tanker label is read in parts: "***SINGLE STRENGTH APPLE JUICE ***VALLEY PROCESSING INC. SUNNYSIDE, WA *** O/TKR LUDFORD'S INC ***PO #53018VP-8 *** BRIX: 11.5 MIN***".
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1955-2019·2019-07-17

    MAHURKAR and Argyle acute hemodialysis catheters recalled for inaccurate priming volume labels

    COVIDIEN LLC is recalling MAHURKAR and Argyle acute hemodialysis catheters because the printed priming volume values are higher than the volumes required to fill each lumen.

    Product
    MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8817142005 8817143005 8817145005 8817146001 8817146007 881714900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1949-2019·2019-07-17

    Helena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits

    Helena Laboratories is recalling ColoCARE diagnostic kits because the positive control failed to react properly, potentially affecting test accuracy.

    Product
    ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
    Category
    Medical Device
    Distribution
    34 states